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Protagonist Therapeutics Receives $1.45 Million SBIR Funding for the Development of PTG-300

-- Grant supports translational research for hepcidin mimetic PTG-300 for potential treatment of rare blood disorders --
-- Phase 2 study in beta-thalassemia expected to begin in the fourth quarter of 2018 --

NEWARK, Calif., Sept. 6, 2018 /PRNewswire/ -- Protagonist Therapeutics, Inc. (Nasdaq: PTGX) today announced the receipt of a Phase 2 Small Business Innovation Research (SBIR) Grant from the National Heart, Lung and Blood Institute of the National Institutes of Health. This award, Number R44HL132702, provides up to $1.45 million over two years to support research aimed at developing the Company's novel hepcidin mimetic clinical drug for the potential treatment of chronic anemia and iron overload in rare blood disorders, including beta-thalassemia.

"This grant recognizes the potential benefit of our hepcidin mimetic PTG-300 in the treatment of blood disorders associated with iron metabolism," said David Liu, Ph.D., Protagonist Therapeutics' Head of R&D and Chief Scientific Officer. "We expect that the results of the research will lead to methods and biomarkers that could be useful in guiding clinical trial design and evaluating clinical results as we explore multiple opportunities to develop PTG-300 in multiple indications. We look forward to the initiation of a global Phase 2 study of PTG-300 in beta-thalassemia in the fourth quarter of the year."

The objective of the SBIR-funded research is to develop methods for characterizing in vivo target engagement, including pharmacokinetic and pharmacodynamic methods to characterize PTG-300 interactions, effects on pathway and disease biomarkers, and effects in pre-clinical disease models.

The content of this press release is solely the views of its authors and does not represent the official views of the National Institutes of Health.

About Protagonist Therapeutics, Inc.

Protagonist Therapeutics is a clinical stage biopharmaceutical company that utilizes a proprietary technology platform to discover and develop novel peptide-based drugs to transform existing treatment paradigms for patients with significant unmet medical needs. PTG-100 is an oral alpha-4-beta-7 integrin antagonist peptide that is under development for potential treatment of inflammatory bowel diseases. PTG-200 is an oral peptide interleukin-23 receptor antagonist in development for the treatment of Crohn's disease. The company has entered into a worldwide license and collaboration agreement with Janssen Biotech for the clinical development of PTG-200. Protagonist is also developing an injectable hepcidin mimetic, PTG-300, for the potential treatment of anemia and iron overload related to rare blood diseases with an initial focus on beta-thalassemia. The company has completed a Phase 1 clinical trial of PTG-300, which established pharmacodynamic-based clinical proof-of-concept in normal healthy volunteers. The U.S. Food and Drug Administration has granted Orphan Drug Designation to PTG-300 for beta-thalassemia for which a global Phase 2 trial is to be initiated in the fourth quarter of 2018. Treatment of patients with myelodysplastic syndromes, hereditary hemochromatosis and polycythemia vera represent additional opportunities for future development of PTG-300.

Protagonist is headquartered in Newark, California, with pre-clinical and clinical staff in California and discovery operations in both California and Brisbane, Queensland, Australia. For further information, please visit

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, the potential for our programs, our research and development plans, the utility of our intellectual property, and the adequacy of our capital resources. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "would," or "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. We discuss many of these risks in greater detail under the heading "Risk Factors" contained in our quarterly report on Form 10-Q for the three months ended June 30, 2018 as filed with the Securities and Exchange Commission. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.


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